Tevogen Updates on TVGN 489 Following Growing Long COVID Patient Interest

Rhea-AI Summary

Tevogen (Nasdaq: TVGN) provided an update on its investigational precision T cell therapy TVGN 489 on Oct 15, 2025, citing growing public interest from Long COVID patients and stakeholders.

The company said a dose-finding clinical trial showed a favorable safety profile and was peer-reviewed and published in Blood Advances. Tevogen plans collaborations with government programs, patient organizations, and major healthcare providers to expedite development and access when regulatory pathways permit, and has created a dedicated Long COVID contact at longCOVID@tevogen.com. The company also stated it is maximizing capital efficiency and maintains access to financing to support advancement toward commercialization.

Positive

• Dose-finding trial showed a favorable safety profile
• Peer-reviewed publication in Blood Advances
• Planned collaborations with government and major providers

Negative

• TVGN 489 is not yet available for broader clinical use
• Company disclosed it may need additional capital to execute plans

Insights

Clinical Development Strategist

Peer-reviewed safety data and a planned collaboration path accelerate TVGN 489’s clinical development, while access and regulatory steps remain key.

Tevogen reports that its dose-finding trial of TVGN 489 showed a favorable safety profile and that those results were peer-reviewed and published in Blood Advances, which supports the scientific credibility of the early data and reduces short-term technical uncertainty about tolerability. The company also states it will engage with government programs, Long COVID groups, and major healthcare providers to expedite development and prepare for broader patient access once regulatory pathways permit.

Risks and dependencies center on next-stage clinical milestones and regulatory clearance for broader use; safety data alone does not establish efficacy or approval. The planned collaborations may help recruitment and access, but concrete timelines, efficacy endpoints, regulatory submissions, and enrollment targets are not specified, so regulatory and evidence milestones remain the primary determinants of impact.

Watch for the company to disclose next-phase trial design and primary endpoints, any regulatory meeting dates or filings, and enrollment start or readout timelines; expect these items to appear within the next 12–24 months if development advances as indicated.

• Company intends to collaborate with government initiatives, Long COVID patient organizations, and major healthcare providers to expedite development of TVGN 489
• In recognition of the high volume of patient inquiries, Tevogen has established a dedicated communication channel for Long COVID updates at longCOVID@tevogen.com

WARREN, N.J., Oct. 15, 2025 (GLOBE NEWSWIRE) -- WARREN, N.J., Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), today issued an update regarding growing public interest in its investigational precision T cell therapy, TVGN 489, under development for COVID-19 and Long COVID.

“We’re deeply moved by the number of Long COVID patients expressing interest in TVGN 489,” said Dr. Ryan Saadi, Chief Executive Officer of Tevogen Bio. “This level of engagement underscores the urgent need for effective and durable solutions. Our team remains fully committed to advancing this science with both urgency and care.”

The Company’s dose-finding clinical trial of TVGN 489 demonstrated a favorable safety profile and provided valuable insights for the next phase of development. The results were peer-reviewed and published in Blood Advances, the journal of the American Society of Hematology.

While TVGN 489 is not yet available for broader clinical use, Tevogen is actively preparing for the next stage of development. The Company intends to collaborate with government initiatives, Long COVID patient organizations, and major healthcare providers to expedite development and maximize patient access once regulatory pathways allow.

In recognition of the high volume of patient inquiries, Tevogen has established a dedicated communication channel for Long COVID updates at longCOVID@tevogen.com, which will be used to share verified information as it becomes available.

Tevogen continues to maximize capital efficiency, maintains access to financing to support growth, and remains focused on sustainable advancement toward commercialization.

Forward Looking Statements

This press release contains certain forward-looking statements, including without limitation statements relating to: Tevogen’s plans for its research and manufacturing capabilities; expectations regarding future growth; expectations regarding the healthcare and biopharmaceutical industries; and Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases and cancer. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “anticipate,” “possible,” “potential,” “goal,” “opportunity,” “project,” “believe,” “future,” and similar words and expressions or their opposites. These statements are based on management’s expectations, assumptions, estimates, projections and beliefs as of the date of this press release and are subject to a number of factors that involve known and unknown risks, delays, uncertainties and other factors not under the company’s control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements.

Factors that could cause actual results, performance, or achievements to differ from those expressed or implied by forward-looking statements include, but are not limited to: that Tevogen will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic conditions; the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; the risk that Tevogen may not be able to develop and maintain effective internal controls; the failure to achieve Tevogen’s commercialization and development plans and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen to grow and manage growth economically and hire and retain key employees; the risk that Tevogen may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; risks related to the ability to develop, license or acquire new therapeutics; the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, approval and commercial development; risks associated with intellectual property protection; Tevogen’s limited operating history; and those factors discussed or incorporated by reference in Tevogen’s Annual Report on Form 10-K.

You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Tevogen undertakes no obligation to update any forward-looking statements, except as required by applicable law.

Contacts
Tevogen Bio Communications
T: 1 877 TEVOGEN, Ext 701
Communications@Tevogen.com

FAQ

What did Tevogen announce about TVGN 489 on Oct 15, 2025 (TVGN)?

Tevogen said its dose-finding trial showed a favorable safety profile, was published in Blood Advances, and it plans collaborations to expedite development.

Is TVGN 489 available for Long COVID patients now (TVGN)?

No. Tevogen stated TVGN 489 is not yet available for broader clinical use and is in further development.

How is Tevogen responding to increased Long COVID patient interest for TVGN 489 (TVGN)?

The company established a dedicated Long COVID contact (longCOVID@tevogen.com) and plans to work with patient groups and providers to improve access when allowed.

Was the TVGN 489 trial peer-reviewed and where was it published (TVGN)?

Yes; the dose-finding trial results were peer-reviewed and published in Blood Advances, journal of the American Society of Hematology.

Does Tevogen have financing to continue TVGN 489 development (TVGN)?

Tevogen said it is maximizing capital efficiency and maintains access to financing to support growth, but noted additional capital may be needed.